Hyman Phelps and McNamara
Firm Publications

FDA Seeks Methods to Better Regulate NGS Products
September, 2016

Next generation sequencing (NGS) is playing an increasingly important
role in clinical research and clinical diagnostics. This expanding
utilization has largely occurred outside of the U.S. Food and Drug Administration’s (FDA’s) regulatory process. In part, this is due to the lack of clear regulatory guidance as to how tests using NGS would undergo regulatory review; NGS-based tests do not neatly fit within the current regulatory model. The lack of clarity makes it difficult for FDA to articulate expectations, and deters companies from submitting applications. Unclear regulatory requirements and pathways make the review process more unpredictable and risky for applicants.

Another thorny issue is product change. While in vitro diagnostic (IVD) tests tend to change over time, NGS tests are far more elastic. Obtaining clearance for an NGS product that is static, e.g., cannot be updated to reflect new data or genetic insights, is not commercially viable. To FDA’s credit, the agency has been working for a number of years to develop clearer guidance on NGS assays, and has solicited substantial public input. On July 8, FDA released two draft guidances. One addresses the acceptability of
curated data bases, and the other data requirements for IVDs for germline mutations. Both documents are important not only for their impact on NGS tests, but also the insights they offer into FDA regulation of other kinds of IVDs.

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If you have any questions regarding the above information, please contact:
Jeffrey N. Gibbs (202) 737-4288 jgibbs@hpm.com